that the product development cycle for the Pharma sector is a long-drawn process and that the industrial operations and products distribution for the Life Sciences sector are agile processes evolving with the regulations and the business environment.
We are committed to offering technical guidance for sourcing strategies, 3rd party-management, QA compliance and project management.
• Qualified / Responsible Persons in CH (as per the relevant Swiss regulations)
• Assessment & gap analysis of Quality Management Systems (QMS)
• Audits : Contract manufacturers (CDMO) - Wholesalers - Third-party logistics
• Validation : Computer systems - Transportation
• QA intelligence : GMP/GDP - ISO 9001 - ISO 13485 - ISO 14001 – ISO 22716
• Process Design & Improvement
• Portfolio Management
• Contract Manufacturing : Design of sourcing processes - RFI/RFQ
Due diligence - Agreements (QTA) - Technology transfer - KPIs
• Specific Projects Management, e.g. Track & Trace and serialization
New product launch - Computer System Validation (CSV)
Data governance - Data protection
(Drugs & Medical Devices)
Switzerland and Europe Middle-East Africa (EMEA)
• Drugs :
- Gap analysis of registration files according to regulatory requirements
- New Registrations (CTD, e-CTD) and maintenance activities for manufacturing sites & products
• Medical Devices :
- New registrations and maintenance activities
- CE file constitution
- Support to Notified Body relations
- PRRC function (MDR)
• Vigilances :
- Vigilance system and master file set up
- Risk Evaluation Reports
- Reviewing SDEAs (Safety Data Exchange Agreements)
- PV System Master File
(Other products)
Switzerland and Europe Middle-East Africa (EMEA)
• Cosmetics :
- Security evaluation (EU Parts A & B)
- PIF (Product Information File) file constitution
- CPNP (Cosmetic Products Notification Portal) notification
- Ghad listing in KSA-MOAIT and DM (Dubai Municipality) registrations in UAE
- Cosmetovigilance
• Food supplements :
- New registrations and maintenance activities
- Responsible Person in Switzerland
- Nutrivigilance
• CBD :
- Cannabis medical and/or cosmetic use expertise
• Product Data governance
• Product Master Data structure and management
• Compliance to the Swiss Data Protection law and GDPR
• ISMS - Information security management system
• Assessment of your teams’ competencies
• Team coaching
• Training: leadership skills, Train the Trainer
• E-learning: development of innovative solutions according to your needs
• Governance & Diversity, Governance & Digital
Our consulting team spans multiple generations and crosses a wide variety of experiences and areas of expertise.
We are entrepreneurs, innovators, academic professors and speakers that come from executive positions in different industries.
For nearly 20 years we have carried out assignments for pharma companies in Europe and the Middle East.
We've always approached every project as a unique partnership,
looking beyond the traditional services to deliver support to project teams with mapping of processes in operations and procurement,
We believe that devoting yourself to something with passion is the key to success.
Nathalie Wardé
Managing director & Sr. consultant
Providing global consulting that meets your objectives starts with listening very carefully to your current and future objectives.
The correct assessment at this stage is critical to delivering faster, better, smarter results for your organization.
Once we’ve gathered all the relevant information our in-house experts can analyze your situation. Our team’s expertise in Pharma consultancy draws upon decades of high level experience working across the EMA regions.
Having shared and reviewed our analysis with you, we’ll propose a solution to meet your requirements, a solution built around our expertise.
Once we’ve developed and agreed on the best approach for your needs, we leverage our in-house capabilities, our external experts and our network to deliver on the execution.
SETTINGUP A LIFESCIENCE COMPANY IN SWITZERLAND
QA/REGULATORY DUE DILIGENCE PROCESS
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INTRODUCTION TO GMDP
GOOD MANUFACTURING & DISTRIBUTION PRACTICE
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INTRODUCTION TO DRUG PRODUCTS TRACEABILITY
ACCORDING TO THE EU FMD - FALSIFIED MEDICINE DIRECTIVE
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MD AND MARKING - EC
HOW TO COMPLY WITH THE SWISS LAW (ODim)
MEDICAL DEVICES CLASSIFICATION RULES
SETTING UP OF THE MARKING FILE
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COSMETICS
REGULATION (EC) NO 1223/2009
CONSTITUTION OF THE PIF FILE (PRODUCT INFORMATION FILE)
REGISTRATION - CPNP PORTAL (COSMETIC PRODUCT NOTIFICATION PORTAL)
Languages : Français / English
MANAGEMENT OF THIRD PARTY MANUFACTURERS
CDMO (CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION) BEST PRACTICES
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QUALITY AGREEMENTS
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PURCHASING IN THE PHARMA SECTOR
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SOURCING IN THE PHARMA SECTOR
Languages : Français / English
INITIATION TO THE CREATION OF NATURAL AND ORGANIC COSMETICS IN COMPLIANCE WITH THE REGULATIONS
NEW FOOD SUPPLEMENT PRODUCT LAUNCH: FROM FORMULATION TO MARKET
ELABORATION OF VIGILANCES TRAININGS ON LOCAL REQUIREMENTS
RISK ASSESSMENT
SUCCEEDING IN YOUR FMEA (Failure Mode Effects Analysis)
THE FUNDAMENTALS OF PROJECT MANAGEMENT
APPLIED TO THE DEVELOPMENT OF NON-PHARMACEUTICAL HEALTH PRODUCTS
BRAINSTORMING / WORKSHOP
TEAMS AND STRESS MANAGEMENT
IA & Data / STRUCTURER VOS DONNÉES GRÂCE À L’ANALYSE DE RISQUES
Structuring your data through risk analysis
IA & Data / ETES-VOUS À JOUR AVEC LA nLPD?
Are you up-to-date with the nFADP ?
PREPARATION TO DATA PRIVACY CERTIFICATION
DATA MANAGEMENT
BUILD YOUR PRODUCT DATA SHEET (DRUG PRODUCTS & MEDICAL DEVICES)
Johnson&Johnson
GSK
Procter & Gamble
Novartis
Ethypharm
Laboratoires Théa
Labatec Pharma
MPI
Guerbet
CICR
Ibn Hayyan
Boiron
CrossPharm
Sanofi
Panpharma
OM Pharma
EHC
Pharmacore
Stragen Pharma
Vetcoop
Ibn AlHaytham
TRB Chemedica
Medtronic Biopharma
Ateliers de la Gérine
Naturalpes
Oftamedic
Atelier réglementaire
Produits topiques
Atelier QA compliance
« Due diligence » réglementaire
Atelier sécurité – la nLPD
1 an après
Atelier réglementaire
Sérialisation en Suisse
1. Imprint
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Contact address
Nad Consulting Sàrl
Chemin Frank-Thomas, 80
1208 Genève
Switzerland
E-mail : info@nadconsulting.ch
Authorized person
Nathalie Wardé-Dunoyer – Présidente & Managing Director
Commercial Registry Entry
Company name : Nad Consulting Sàrl
Commercial register N° :CHE-201.261.194
VAT number : CHE-201.261.194
Disclaimer :
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2. Privacy Notice
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Privacy policy, use of cookies and legal notice
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When you request information or send us other requests, we ask for your name and other personal data. It is up to you to decide whether you wish to provide us with this information. We store your personal data on servers. Access to these servers is only possible for a few authorised persons. These are the people in charge of the servers, the technical service, sales staff and content editors.
If a personal data is required to respond to your requests, it will be stored for a maximum of six months after the data is collected. If this data is necessary to comply with the legal or contractual retention period, this information will be stored beyond this period. However, this data is locked and accessible to only a few authorised persons.
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Links to other websites
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Google
Data protection:
This website uses Google Analytics, a web analysis service provided by Google, Inc ("Google"). The information collected as part of this service will be processed in accordance with the following terms, for which Google alone is responsible: Google Analytics uses "cookies", which are files placed on your computer, to help the website analyse how users use the site. The information generated by the cookie about your use of the website (including your IP address) will be transmitted to and stored by Google on servers in the United States. Google will use this information for the purpose of evaluating your use of the website, compiling reports on website activity for website operators and providing other services relating to website activity and internet usage. Google may also transfer this information to third parties where required to do so by law, or where such third parties process the information on Google's behalf. Google will not associate your IP address with any other data held by Google. You may refuse the use of cookies by making the appropriate settings on your browser, however please note that if you do this you may not be able to use the full functionality of this website. Please note, however, that if you do this you may not be able to use the full functionality of this website. By using this website, you consent to the processing of data about you by Google in the manner and for the purposes set out above.
Collection and processing of personal data
Personal data is only collected if you give it to us yourself, for example when concluding a contract, in a survey or for access to personalised services.
Web host :
Limitation of liability
We appreciate your interest in our website. Despite careful checking, we cannot accept any liability for the content of external links placed on this website. These external links were checked when they were set up but may be modified subsequently.
Management of personal data
We attach great importance to protecting the privacy of visitors to our website. Your personal data is protected. No personal information is published, transferred or sold to third parties.
Cookies
Cookies are small pieces of data stored by your browser on your computer's hard drive.
We use cookies on our site. These cookies are necessary so that you can move freely around the site and use all the functions, such as access to secure areas of the site, etc. Cookies enable us to identify repeat visitors to the site. Which parts of the site are the most popular. Session cookies store information about your activities on our website.
When you leave the website, for example by clicking on one of the site's external links, and access third-party sites, these sites set cookies. Nad Consulting is not legally responsible for these cookies. To find out how these cookies are used, please consult the privacy statements of the providers of the sites you visit.
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